Foods
|
FY 1999 Actuals |
FY 2000 Pre-Rescission Appropriation |
FY 2000 Final Appropriation |
Increases |
FY 2001 Estimate |
Direct Appropriation1 |
$235,168 |
$269,245 |
$267,449 |
$35,108 |
$302,557 |
Other User Fees2 |
|
|
|
$26,350 |
$26,350 |
Total |
$235,168 |
$269,245 |
$267,449 |
$61,458 |
$328,907 |
FTE |
2,339 |
2,391 |
2,378 |
316 |
2,694 |
1/ Includes Salaries & Expenses, Rent and PDUFA, where applicable.
2/ For FY 2001, the proposed Export Certification User Fee is included in the
Foods Program. Should appropriate user fee legislation be enacted, the FY 2002
budget will reflect this user fee in the Export Certification line of the budget,
not the Foods Program line.
EXPLANATION OF PROGRAM
The Foods Program has the primary responsibility for assuring that the US food
supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic
products are safe and properly labeled. Since foods are susceptible to a wide
variety of potentially hazardous substances including microbial pathogens, chemical
residues, natural toxins, and illegal food additives, the Foods Program has
an enormous responsibility that has a direct impact on the health of individual
consumers as well as the entire nation.
FDA ensures the quality and safety of foods while dealing with the increased
responsibilities of additional statutory authorities and implementation of government
reinvention initiatives to improve efficiency and effectiveness. The variety
and complexity of the food supply has grown dramatically while new and more
complex safety issues, such as emerging microbial pathogens, natural toxins,
and technological innovations in production and processing, have developed.
This program plays a major role in keeping the United States food supply among
the safest in the world.
FY 2001 BUDGET REQUEST
ASSURING SAFETY/STRENGTHENING SCIENCE INITIATIVES
PREMARKET INITIATIVES + $1.2 MILLION, 5 FTE
Bringing Products of New Technology to Market + $1.2 million, 5
FTE
FDA will focus on two critical program areas - biotechnology and dietary supplements.
Improved scientific knowledge in these areas will lead to safer products by
helping the Agency better understand the complexities of the products it is
regulating.
- Analyze risks associated with emerging technologies, specifically biotech
foods. This information allows FDA to make well-informed regulatory decisions.
- Develop sound scientific data and expertise to support standards and guidance
in evaluating the safety of dietary supplements. Use analytical techniques
and sampling methodologies for ingredients, contaminants, pre-clinical testing,
and models for assessing human risk.
Provide consumers quicker access to new food ingredients and dietary
supplements, while assuring their safety and effectiveness. 3 (Foods Strategic Goal # 1)
Respond to 90 percent of notifications for dietary supplements containing
"new ingredients" within 75 days. (Foods Performance Goal # 3)
POSTMARKET INITIATIVES + $9.2 MILLION, 17 FTE
Adverse Event Reporting System (AERS) + $2.5 million, 2 FTE
Dietary supplements are not subject to a premarket safety review or approval
by FDA. Post-market surveillance activities, including monitoring of adverse
events associated with marketed products, are critical for FDA to monitor the
safety of these products. There are an increasing number of adverse event reports
involving drug interactions in individuals using dietary supplements. To counter
this trend, FDA will:
3 We have attempted
to align the budget request and performance plan goals. All italicized items
represent performance goals in the Agency's performance plan, with the specific
reference following. More information on these goals and past performance can
be found in the performance plan.
- Enhance the AERS for dietary supplements and develop a system component
to collect data on drug-dietary supplement interactions to provide a faster,
more efficient way to evaluate adverse event reports, thus shortening the
time needed for any responsible actions, potentially saving lives and improving
public safety.
Reduce the health risks associated with food and cosmetic products
by preventing human exposure to hazards, monitoring product quality and
correcting problems that are identified. (Foods Strategic Goal # 2)
Inspectional Activities + $1.7 million, 15 FTE
Complementary to inspectional coverage under the Food Safety Initiative, FDA
is requesting additional resources to improve the monitoring of dietary supplements,
pesticides, and chemical contaminants. FDA will:
- Expand dietary supplement compliance inspections and sample analyses to
better protect consumers.
- Expand monitoring for pesticides and environmental contaminants in foods,
including a focus on imports, to meet the requirements of the Food Quality
Protection Act (FQPA).
Continue to expand monitoring for pesticides and environmental contaminants
in foods through the collection and analysis of a targeted cohort of 11,000
samples. (Foods Performance Goal # 16)
- Revise and expand the FDA Total Diet Program to obtain data on levels of
pesticides, industrial chemicals, toxic elements, and vitamins and minerals
in foods that is more representative of today's consumer eating habits. This
will enable FDA to estimate the risks of pesticides and chemical contaminants,
and the level of food nutrients in the American diet.
- Replace outdated field laboratory equipment to improve the accuracy and
timeliness of food product analyses to determine compliance with safety requirements.
- Expand the ability of Federal, State and local partnerships to improve food
safety by expanding the ability of FDA's partners to share data through the
field data systems.
- Establish Quality Management System procedures as a normal part of all field
food program activities to increase consistency and quality of field activities
nationwide. This is an internal quality system based on ISO 9000 internationally
accepted quality standard. It involves a quality information base for system-wide
evaluation and assessment. This Quality Management System integrates all field
work products and processes: investigative, scientific and enforcement. This
unified management system will improve dissemination of scientific and management
policy and preserve institutional knowledge.
College Park Relocation + $5.0 million
In 2001, the Center for Food Safety and Applied Nutrition (CFSAN) will be moving
to a newly constructed facility in College Park, Maryland. Funds are needed
to pay for one-time costs associated with equipping and occupying this facility.
The FY 2001 funding will support: telecommunications equipment and necessary
network connections; and files consolidation and moving costs.
USER FEES
Proposed New User Fees + $13.7 million, 78 FTE
PREMARKET
Direct Food Additive Petition User Fees + $8.4 million, 55 FTE
Industry support is evident for additive user fees for food additive petitions.
The food industry has indicated that their objective is to have a food additive
approval process that can regularly deliver high quality and timely scientific
reviews and decisions on food additive petitions so that food safety is protected
and innovation in food technology is not deterred by the regulatory process.
FDA is proposing fees to supplement rather than replace funding from general
revenues for review of direct food additive petitions. Additional resources
would enable the Agency to take a number of steps to improve its review of products.
This would include enhanced training to support the scientific expertise of
reviewers that need to keep pace with increasingly complex products, and prefiling
consultations with petitioners.
Complete first action on 50 percent of food and color additive petitions
within 360 days of receipt. (Foods Performance Goal # 1)
POSTMARKET
Food Export Certificate User Fees + $5.3 million, 23 FTE
Food exporters are required to comply with an increasing number of European
Union (EU) requirements for certificates attesting to the safety of animal-derived
foods. Such certificates attest to product compliance with EU directives and
standards, not FDA regulations. In order to provide such certificates to US
food exporters, the Agency may need to conduct more frequent inspections or
analyze products for the presence of substances that may not be considered significant
public health risks in the US. FDA must recoup the costs incurred as a result
of such inspections or laboratory analyses, and administrative costs associated
with issuance of export certificates. Authority currently exists for such a
recoupment for Human Drugs, etc. This would merely extend the same authority
to the Foods program. A legislative proposal is being forwarded by the Administration.
FDA expects to issue approximately 30,000 export certificates per year at a
cost of $175 per export certificate under this provision. This would yield $5.25
million per year in revenue.
Proposed Transfer of User Fees
POSTMARKET
Seafood Inspection Transfer + $12.7 million, 139 FTE
The Seafood Inspection Program under the National Marine Fisheries Service
(NMFS)/National Oceanic Atmospheric Administration (NOAA)/US Department of Commerce
(USDC) provides voluntary inspections and certification services for fish and
fishery products on a fee-for-service basis under the authority of the Agricultural
Marketing Act of 1946, and also addresses issues of wholesomeness, economic
integrity and quality.
The budget proposes: 1) a transfer of this program from the Commerce Department
to the Department of Health and Human Services, under the purview of the Food
and Drug Administration, through appropriations language; and 2) the transmittal
of legislation to make this program into a Performance Based Organization, still
under the auspices of FDA, but to run more like a business. The transfer and
subsequent conversion to a PBO will remove unnecessary bureaucratic constraints
and allow the program to respond more promptly to the needs of its customers;
thereby, actively pursuing the goals of the Agricultural Marketing Act for the
benefit of industry and consumers.
SPECIAL PROGRAM INITIATIVES
Food Safety Initiative + $21.6 million and 122 FTE
FY 2001 will mark the fourth year of a highly successful multi-agency initiative
to control and reduce foodborne pathogens in the American food supply. The benefits
of this investment are evidenced by the fact that the time it takes to respond
to numerous outbreaks have been shortened, resulting in fewer potential deaths
and illnesses to American consumers.
In FY 2001, FDA will further strengthen and enhance Federal, State and local
food safety systems through the use of uniform minimum standards and practices
for inspections and consistent enforcement. In collaboration with its sister
agencies, the FDA will conduct the following activities to improve inspectional
coverage and related research efforts.
Inspections + $17.0 million, 116 FTE
- Expand domestic inspections to ensure annual inspections of all high-risk
food establishments and enhance laboratory capabilities for the analytical
support associated with this level of inspectional activity. Examples of high
risk establishments include: processors of infant formula; establishments
that process ready to eat foods, or produce heat and serve products; establishments
that process seafood products, all low- acid canned food processing plants,
and processors of juice.
Increase the percentage of high-risk domestic food establishments inspected
once every year to 100 percent. (Foods Performance Goal # 10)
- Implement State audit programs to ensure consistent application of regulations,
e.g., Seafood HACCP.
- Expand the application of HACCP systems with the implementation of the HACCP
for fruit and vegetable juices.
Develop the HACCP final rule for fruit and vegetable juices. (Foods Performance
Goal # 22)
Research and Risk Assessment + $4.6 million, 6 FTE
- Develop a Risk Strategic Plan to expand the understanding of science-based
inspection programs, risk assessment models, data and assessments and to provide
information and predict the risk associated with specific pathogens.
- Develop consistent nationwide standards for on-farm preventive controls
for egg producers and food handling practices at retail.
- Develop and evaluate on-farm intervention strategies and/or technologies
to improve testing methodologies for Salmonella Enteriditis (SE)
on the farm and in eggs, and to understand the ecology and epidemiology of
SE in the hen and farm environment.
Countering Bioterrorism + $1.2 million and 3 FTE
FDA will conduct the following activities as part of an overall strategy to
safeguard the food supply from potentially harmful and lethal biological agents.
- Conduct research to develop rapid methods of detection of biological agents,
such as anthrax, that could be used by terrorists. Techniques will
be developed to confirm the results of less specific detection methods. These
detection methods will provide necessary surveillance tools needed for monitoring
programs.
- Work with other governmental agencies (domestic and international) and private
sector organizations to develop cooperative programs to exchange information
regarding surveillance activities and develop improved crisis management procedures
for bioterrorism incidents.
- Participate in the planning and coordination of public health responses
to bioterrorist attacks.
- Prepare field staff to safely seize, remove, and dispose of contaminated
products by developing procedures and providing appropriate facilities and
equipment.
- Develop inspection methods and procedures to assure the safety of regulated
products at manufacturing sites and other establishments.
JUSTIFICATION OF BASE
FDA's Foods program will continue to ensure the safety of foods and cosmetics
through its activities of premarket review and postmarket surveillance and the
National Food Safety Initiative. The Agency develops standards and/or regulations,
conducts related research to provide the necessary scientific basis for its
regulatory decisions, monitors the marketplace, inspects, works extensively
with all stakeholders, uses market research to develop effective strategies,
tracks and analyzes adverse event reports, and participates in international
standard-setting activities. FDA's Foods program will continue to carry out
activities in the following areas:
- Premarket Review of food ingredients, using chemical, toxicological, and
environmental analysis. Ingredients that relate to significant reductions
in microbial pathogens in foods will receive an expedited review process.
- Health and safety labeling issues ranging from health or nutrient content
claims to warnings for special populations, including infant formula and medical
food product labeling.
- Dietary supplements, including effective regulation under the Dietary Supplement
Health and Education Act (DSHEA).
- Pesticide and industrial chemical contamination, including developing procedures
for the safe and sanitary processing of foods, such as the HACCP preventative
control system model used for processing seafood and juice.
- Cosmetics, including the Voluntary Cosmetic Registration Program (VCRP),
a program designed to collect ingredient and manufacturing data from manufacturers
and provide feedback to all stakeholders (industry, consumers, etc.).
The President's Food Safety Initiative has successfully put into place a strong
foundation for a science-based, integrated food safety system that has resulted
in reductions in the incidence of death and illness attributable to foodborne
pathogens. Some of the key activities include:
- Surveillance, to identify, contain, and respond to foodborne outbreaks,
as well as assess antimicrobial resistance. Three systems are now in place
and nearing full operation. FoodNet is a foodborne disease tracking system
that provides information to estimate the frequency and demographic distribution
of foodborne illnesses in the United States. PulseNet is a computerized database
of bacterial DNA subtypes that can be used to quickly determine whether illness
occurring in different geographic locations during the same time frame are
linked to a common food source. The National Antimicrobial Resistance Monitoring
System (NARMS) allows for identification of disease trends, such as antibiotic
resistance among foodborne pathogens, in human and animal medicine, and monitors
the transfer of antibiotic resistant bacteria to humans.
- Inspections in the industry promote and verify the use of techniques
that prevent microbiological contamination of both domestic and imported foods.
FDA is pursuing similar strategies for domestic and imported foods by using
existing expertise and information generated from surveillance, research,
and risk assessments to target inspections and preventive measures toward
the greatest risk, and to ensure that good manufacturing practices are followed.
FDA is developing science-based solutions to the Nation's food safety problems.
The Hazard Analysis and Critical Control Point (HACCP) concept, which is currently
implemented by the seafood industry, is a scientific program where manufacturers
and food preparers identify points in a process where safety problems can
occur and establish measures to effectively prevent the problems.
- Educational messages targeted along the farm-to-table continuum, particularly
to those in the most vulnerable groups have been very successful. These messages
provide information to improve awareness and knowledge of safe food practices.
Survey results show increased incidence of safer food handling practices by
consumers since the campaign began.
- Microbiological research and the development of risk assessment techniques
provide the scientific basis for the integrated food safety system. Inspection
and surveillance activities in particular require the development of science-based
tools through research. Most contamination is no longer detectable by simple
visual review, but rather is microbial in nature and requires sophisticated,
state-of-the-art technologies to detect and control. These activities are
critical in providing information about pathogens, how they enter and interact
with the human body, and the best methods for attacking them.
Foods
Selected FY 1999 Accomplishments
|
Direct Appropriations |
Other Appropriations |
Program
Level |
FTE |
FY 1996 |
$200,941 |
$0 |
$200,941 |
2,348 |
FY 1997 |
$191,183 |
$0 |
$191,183 |
2,226 |
FY 1998 |
$206,249 |
$0 |
$206,249 |
2,239 |
FY 1999 |
$235,168 |
$0 |
$235,168 |
2,339 |
FY 2000 est. |
$267,449 |
$0 |
$267,449 |
2,378 |
Food Safety Initiative
- Increased surveillance of imported food overseas and at the border. Also,
enhanced follow-up and containment of foodborne disease outbreaks associated
with imported food.
- Developed a farm investigation questionnaire for use on farms implicated
in produce tracebacks has also been developed to provide standardized detailed
information.
- Conducted 19 traceback investigations involving FDA regulated products,
and visited 10 farms as the result of outbreak tracebacks or positive samples
in the Imported Produce Sampling Program.
- Disseminated and promoted the use of the Good Agricultural Practices/Good
Manufacturing Practices guidance document to both domestic and foreign agriculture
communities, in conjunction with USDA.
- Initiated education/outreach and technical assistance to foreign countries
on the use of Good Agricultural Practices (GAP)/Good Manufacturing Practices
(GMP) guidance for produce. A six-minute video, "Assuring Safer Produce: A
Global Issue," was completed. This new tool provides an overview of the good
agricultural and good manufacturing practices, helps explain the Produce Safety
Initiative, and is available in four languages. This will improve the safety
of foods imported into this country.
- Assessed the food safety systems in Nicaragua, Costa Rica, El Salvador,
Guatemala and Honduras, which export a significant amount of food to this
country.
- Developed a specialized egg safety campaign to reduce the incidence of foodborne
illnesses caused by Salmonella Enteritidis. Two fact sheets were
developed: "Playing it Safe with Eggs" for consumers and "Assuring the Safety
of Eggs" for food service personnel.
- Proclaimed September 1999, as National Food Safety Education Month. This
was an opportunity to promote food safety to consumers and the food industry.
This year's theme was "Cook It Safely". FDA, in conjunction with USDA, developed
and mailed consumer education guides to public health departments, FDA public
affairs specialists and USDA extension agents throughout the country. The
guide contained activities and publicity ideas for food safety education during
September.
Food Safety: Premarket Review of Food Ingredients
- Implemented new procedures to expedite the review of food additives to decrease
the incidence of foodborne illness through its antimicrobial action against
human pathogens that might be present in food. The first petitions to meet
the criteria for expedited review included antimicrobial agents in the processing
of poultry, seafood, fruits, and vegetables, and irradiation of fresh shell
eggs.
- Published "Antimicrobial Food Additives - Guidance," designed to clarify
FDA's jurisdiction over antimicrobials that are used in food or that may become
a component of food. This document provides guidance that is important in
delineating the jurisdiction of FDA and EPA over antimicrobial substances,
and the regulatory authority over inert ingredients of certain pesticide formulations.
- Completed "first action", defined as a review of all parts of a petition,
followed by issuance of a "not approvable" letter, or publication of a response
in the Federal Register, on 54 percent of food and color additive
petitions within 360 days of receipt, a 12 percent improvement over the FY
1999 goal.
- Reduced the percentage of overdue food and color additive petitions to 30
percent from 38 percent of petitions in process for more than 360 days.
- Developed a new notification program for Generally Recognized as Safe (GRAS)
food additive petitions to replace the current lengthy rule-making process.
Manufacturers will simply notify FDA of their GRAS determination and provide
evidence that supports their decision. After which FDA has 90 days to respond.
- Published a final rule for dietary supplement labeling. Consumers will now
see more complete information on dietary supplement products, including an
information panel titled "Supplement Facts", a clear identity statement and
a complete list of ingredients.
- Published the proposed rule for requiring the amount of trans fatty
acids in a food to be included on the Nutrition Facts label. Included in this
proposal is a new nutrient claim defining "trans fat free". Consumption
of trans fatty acids has been shown to increase blood LDL-cholesterol
("bad" cholesterol) levels and increase the risk of coronary heart disease.
Prepared and distributed outreach materials to prepare industry, consumers,
and health professionals for the proposed trans fatty acids labeling
requirement.
- Published the proposed rule and prepared the final rule allowing the Health
Claim for soy proteins reducing the risk of coronary heart disease, and for
whole grain foods reducing the risk of coronary heart disease and certain
cancers. Received and responded to both nutrient content claims/health claim
petitions within 100 days with a decision to the petitioner.
- Published a final rule to amend the ingredient labeling regulation for surimi
and surimi-containing foods in response to a petition submitted by the National
Fisheries Institute (NFI) requesting more flexible ingredient labeling.
Food Safety: Postmarket Surveillance
- Advanced the Hazard Analysis and Critical Control Point (HACCP) Programs
designed to prevent potential hazards. Kept the Seafood HACCP Program on track
with the full expectation that 50 percent of the domestic seafood industry
will be using preventative controls for safety as evidenced by operating HACCP
systems. Programs to educate seafood processors in the design and operation
of HACCP systems have been on-going and we have updated and upgraded our guidance
materials.
- Targeted foreign inspections toward developing countries with large volumes
of seafood exports to the United States, to ensure international compliance
with HACCP. We are also pursuing equivalence agreements with our more advanced
seafood training partners. We have upgraded the education provided to our
own inspectors, offering certification programs and the same training offered
to the industry.
- Published the proposed rule for Juice HACCP to require processors of packaged
fruit and vegetable juices to implement HACCP to prevent contamination of
their products.
- Sponsored a voluntary HACCP Pilot Program for Grade 'A' dairy products in
partnership with the National Conference on Interstate Milk Shipments, designed
to determine if HACCP can be accepted as an alternative to the traditional
inspection system in the Pasteurized Milk Ordinance.
- Emergency Operations: Responded to possible public health
emergencies resulting from natural disasters, such as the floods in the Southeast
caused by hurricane Floyd, and reports of illnesses or injury that are associated
with a regulated product and must be investigated. Below are examples of emergencies
that required extensive investigation and follow-up:
Pathogen |
Product |
States Involved |
Listeriosis |
Cheese |
CT, NY, OH, MA |
Salmonella baildon |
Tomatoes |
CA, VA, AZ, GA, TN, IL, AL, KS |
Salmonella mbandaka |
Alfalfa Sprouts |
OR, CA |
E.coli 0157:H7 |
Lettuce |
NE |
Salmonella typhi |
Guatemalan Mamey |
FL |
Salmonella thompson |
Mexican Cilantro |
CA |
Shigella sonnei |
Tomatoes or Basil |
CT, MA |
Enterobacter sakasaki |
Infant Formula |
FL |
Salmonella typhimurium |
Clover Sprouts |
CO |
Botulism |
Hash Brown Potato Patty |
IA |
Shigella |
Foodborne Outbreak |
AZ |
Salmonella St. Paul |
Clover Sprouts |
CA |
Salmonella muenchen |
Orange Juice |
OR, WA |
Cyclospora |
Fruit Plate |
CA, WI |
E. coli 0157:H7 |
Cabbage |
OH |
- Implemented a plan with the US Customs Service to prevent unsafe imported
food from crossing our borders which:
- requires shipments of unsafe food to be held in a secure storage facility
at the importer's expense until released by FDA and Customs;
- permits the destruction of foods that are refused entry due to a serious
public health and/or safety violation;
- requires refused food shipments not meeting US Standard to be marked
"Refused" to indicate that the product was denied entry into the US;
- establishes standards for importer, contractors, and private laboratories
that collect and analyze samples of import food for the purpose of gaining
entry into the US;
- increases the amount of bond posted for imported foods to the full market
value of the product to deter illegal entry into the US; and uses civil
money penalties against importers who attempt to enter food into the US
by means of false statement, act, or admission.
- USDA FSIS/FDA Memorandum of Understanding (MOU): FDA and
the USDA Food Safety and Inspection Service (FSIS) signed a MOU to share information
and cooperate in the regulation of dual jurisdiction establishments that produce
products regulated by both agencies, making joint inspections and joint enforcement
actions possible.
- Import Produce Analyzed for Pathogens: Analyzed over 550
samples of fresh imported produce for microbiological pathogens. This first
systematic look at this dietary significant group of foods for pathogens found
approximately 5 percent of the samples contained pathogens. Pathogens detected
were Shigella and Salmonella spp. Commodities found positive
included: cantaloupe, celery, cilantro, green onions, lettuce, and parsley.
Cosmetics
With the $2.5 million provided by Congress for the Cosmetics program, FDA:
- Reinstated the Cosmetic Voluntary Reporting Program, to provide quantitative
and descriptive data which protects consumers against potentially hazardous
cosmetic ingredients and products.
- Completed a clinical study on the effects of Alpha Hydroxy Acids (AHAs),
used in some skin preparations, on human skin that will help to support Agency
decisions concerning possible public health risks.
- Worked collaboratively with the National Toxicological Program (NTP) in
the development of a state-of-the-art phototoxicity testing facility and photocarcinogenicity
testing protocol for studying the long-term effects of AHAs on the adverse
effects of sunlight.
Foods
Program Activity Data
Program Workload and Outputs |
FY 1999
Actuals |
FY 2000 Estimate |
FY 2001 Estimate |
Food and Color Additive Petitions
Completed1
Percentage of Overdue Petitions under review1 |
54%
42% |
40%
N/A |
50%
N/A |
Inspections - FSI by FDA 2
Non-HACCP - Foreign
Non-HACCP - Domestic
Seafood HACCP - Domestic
Seafood Importer (HACCP) |
110
3,248
2,679
655 |
250
3,700
2,600
800 |
250
4,000
2,600
1,000 |
Inspections - FSI by State Contract 2
Non HACCP
Seafood HACCP |
3,345
550 |
4,200
600 |
4,700
600 |
Inspections - FSI by State Partnerships 2
Non HACCP
Seafood HACCP
Seafood Importer HACCP |
2,767
866
11 |
3,000
800
10 |
3,200
800
10 |
Total FSI Inspections
Import
Domestic |
765
14,121 |
1,050
14,910 |
1,050
15,910 |
Inspections - Non FSI by FDA 2 |
559 |
800 |
1,100 |
Field Exams3
Import - FDA FSI
Domestic - FDA FSI
Import - FDA Non-FSI
Domestic - FDA Non-FSI |
9,144
86
6,684
1,906 |
9,400
100
6,700
2,000 |
9,400
100
6,700
2,000 |
Laboratory Samples Analyzed4
Import - FSI
Domestic - FSI
Import - Non-FSI
Domestic - Non-FSI |
14,949
3,804
1,490
5,531 |
15,000
4,000
1,500
5,000 |
15,000
4,000
1,900
5,500 |
_______________
1/ The percentage of Food and Color Additive Petitions Completed is based upon
360 days. The goals for first action for petitions (FYs 2000 and 2001) are lower
than those achieved in FY 1999 due to the conversion of petitions to notifications
in FY 2000. FDA expects there will be a dramatic change in both the number of
petitions under review and those overdue. FDA will establish new baseline numbers
for these goals at the end of FY 2000.
2An inspection is any visit to an establishment during which all
or part of one or more phases of that establishment's operation is evaluated
against appropriate FDA requirements.
3Field Exams are the on-site examination of a product that is sufficient
in itself to determine that the product is in compliance with FDA requirements.
4Laboratory Samples Analyzed are product samples physically analyzed
by the laboratory to determine whether or not the product is in compliance with
FDA requirements.
Edited 3/1/2000